Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Autologous Adipose Derived Mesenchymal Stromal Cells (AD-MSC) Transplantation in Ultra Filtration Failure (UFF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02801890
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Royan Institute

Tracking Information
First Submitted Date  ICMJE June 12, 2016
First Posted Date  ICMJE June 16, 2016
Last Update Posted Date April 27, 2017
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2016)
  • Systemic infection [ Time Frame: 6months ]
    Evaluation the rate of systemic infection in patients with UFF after cell therapy.
  • Hepatic failure [ Time Frame: 6 months ]
    Evaluation the rate of hepatic failure in patients with UFF after cell therapy.
  • Renal failure [ Time Frame: 6 months ]
    Evaluation the rate of renal failure in patients with UFF after cell therapy.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02801890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2016)
  • Ratio of 4-hour dialysate/plasma creatinine (D/P Cr). [ Time Frame: 6 months ]
    Evaluation the change of (D/P Cr) in patients with UFF after cell therapy.
  • Ratio of 4-hour dialysate/plasma urea (D/P urea ) [ Time Frame: 6 months ]
    Evaluation the change of D/P in patients with UFF after cell therapy.
  • Ratio of dialysate glucose concentrations (D/D glucose ) [ Time Frame: 6 months ]
    Evaluation the change of D/D glucose in patients with UFF after cell therapy.
  • peritoneal membrane transport function [ Time Frame: 6 months ]
    Assessment of peritoneal membrane transport function by peritoneal equilibration test (PET)
  • Glomerular filtration rate (GFR): [ Time Frame: 6 months ]
    Evaluation the change of Glomerular filtration rate (GFR) in patients with UFF after cell therapy.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Autologous Adipose Derived Mesenchymal Stromal Cells (AD-MSC) Transplantation in Ultra Filtration Failure (UFF)
Official Title  ICMJE Autologous AD-MSC Transplantation in Peritoneal Dialysis Patients With Ultra Filtration Failure and Evaluation of Cellular and Molecular Effects of Mesenchymal Stem Cell Infusion on Peritoneal Fibrosis
Brief Summary

Peritoneal fibrosis may be occurred as a serious complication of peritoneal dialysis. It's the main factor of UFF that could lead to the Encapsulating Peritoneal Sclerosis (EPS). Using the potential features of MSCs in the treatment of fibrosis may offer new insights into reconstruction the damaged tissues. The project intends to transplant autologous MSCs to ten peritoneal dialysis patients with ultra-filtration failure. It's going to study infusion effects in clinical, cellular and molecular levels.

So in this trial, we will evaluate the effects of this intervention after intravenous injection of autologous adipose derived mesenchymal stem cells in 10 peritoneal dialysis patients with ultra filtration failure (UFF). Fifteen UFF patients are also considered as the control group. Then they will be followed 20, 45 and 90 days, and also 4 and 6 months after first injection.

Detailed Description

Chronic kidney disease is defined as a reduced glomerular filtration rate, increased urinary albumin excretion, or both, and is an increasing public health issue. Prevalence is estimated to be 8-16% worldwide. Stage 5 CKD is often called end-stage kidney disease and usually means that the patient requires renal replacement therapy (RRT), which may involve a kidney transplant or a form of dialysis. One of the options in RRT is continuous ambulatory peritoneal dialysis (CAPD). CAPD is characterized by a continuous removal of extracellular fluid by peritoneal membrane. It should be noted that like any other peritoneal dialysis therapy, CAPD has Short or long-term complications and UFF is the most common functional disorder in which the peritoneal ultrafiltration membrane damaged.

This project intends to evaluate, the role of autologous mesenchymal stem cells in improvement of peritoneal membrane function in peritoneal dialysis patients who have ultrafiltration failure up to 6 months.

In this study, 10 male and female subjects who are on peritoneal dialysis for at least two years and have ultrafiltration failure with age range of 18 to 70 years will be enrolled. Patients will be selected from peritoneal dialysis patients attending the peritoneal dialysis ward of Dr. Shariati hospital. The main inclusion criteria is to be on peritoneal dialysis for at least last two years and having Ultrafiltration failure. After obtaining the consent form, a sample of fat tissue will be obtained by a general surgeon under sterilized condition from patients and then in the specialized lab, the mesenchymal stem cells will be separated and cultured to reach appropriate numbers (106/kg). The cells will be injected through peripheral vein in hospital setting. Patients will be followed-up (clinically and laboratory) at baseline and at week 3, week 6, month 3, month 4 and month 6. The clinical assessment and peritoneal function tests will be performed in each visit. Outcome measures: The main outcome measures that periodically will be assessed include: D/P cr, D/P urea, D0/D glucose, PET, KT/V urea, Glomerular filtration rate (GFR)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ultra Filtration Failure
Intervention  ICMJE Biological: Intravenous injection
Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .
Study Arms  ICMJE
  • Experimental: AD-MSC
    The patients with ultra filtration failure (UFF) underwent AD-MSC injection.
    Intervention: Biological: Intravenous injection
  • Placebo Comparator: Placebo
    The patients with ultra filtration failure (UFF) underwent Placebo injection.
    Intervention: Biological: Intravenous injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2016)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. peritoneal dialysis for at least last two years and
  2. Ultrafiltration failure
  3. Both genders
  4. Age 18-70 years
  5. inform consent signing

Exclusion Criteria:

  1. Inability of patients to attend visits and regular testing
  2. Estimated lifetime less than one year
  3. Use of immunosuppressive drugs
  4. Pregnancy
  5. Malignancy
  6. Coagulative disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02801890
Other Study ID Numbers  ICMJE Royan-kidney-006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Royan Institute
Study Sponsor  ICMJE Royan Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Nasser Aghdami, MD,PhD Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Study Director: Gholamreza Pourmand, MD Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.
Study Director: Iraj Najafi, MD Urology Research Center, Sina Hospital, Tehran University of Medical Sciences, Iran.
Principal Investigator: Sudabeh Alatab, MD Sudabeh
Principal Investigator: Soroosh Shekarchian, MD Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Principal Investigator: Reza Moghadasali, PhD Department of Regenerative Biomedicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
PRS Account Royan Institute
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP